Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in left ventricular ejection fraction by echocardiogram |
The change in left ventricular ejection fraction from baseline as determined by echocardiography |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Quality of Life score on the Minnesota Living with Heart Failure questionnaire |
Numerical score based on a subject's subjective symptoms and functional status |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Quality of Life score on the Kansas City Cardiomyopathy Questionnaire |
Numerical score based on a subject's subjective symptoms and functional status |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
6-minute walk distance |
Distance on a standard 6-minute walk measured in meters |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Cardiopulmonary exercise test maximum oxygen consumption |
V02max (maximum milliliters of oxygen consumed per kilogram of body weight per minute) |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Cardiopulmonary exercise test metabolic equivalents achieved |
metabolic equivalents (METs) |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Cardiopulmonary exercise test peak power output achieved |
peak power output (watts/kilogram) |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
Cardiopulmonary exercise test total exercise time |
total exercise time (minutes) |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
daily minutes of sedentary activity |
CamNtech motion watch 8 average daily minutes of activity in the sedentary range |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
daily minutes of low activity |
CamNtech motion watch 8 average daily minutes of activity in the low range |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
daily minutes of moderate activity |
CamNtech motion watch 8 average daily minutes of activity in the moderate range |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
daily minutes of vigorous activity |
CamNtech motion watch 8 average daily minutes of activity in the vigours range |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
major adverse cardiac events |
MACE |
at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. |
|
Secondary |
symptom score during the intervention/sham procedure |
An aggregate score of a subject's subjective report of shortness of breath, chest pain, palpitations, lightheadedness, each on a scale of 0-10. Minimum score 0, maximum score 40. |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
maximum achieved pacing rate during the intervention/sham procedure |
measured in beats/minute |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
presence of significant arrhythmia during the intervention/sham procedure |
binary outcome of 0 (no such arrhythmia) versus 1 (presence of a significant arrhythmia) during each episode of pacing. A significant arrhythmia refers to either subject-reported symptoms during the arrhythmia, or a change in systolic blood pressure of 20 mmHg from that immediately before the onset of the arrhythmia, or an arrhythmia requiring intervention to terminate. |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
vital signs - systolic blood pressure during the intervention/sham procedure |
maximum change in systolic blood pressure (millimeters of mercury) during the intervention/sham period versus the baseline blood pressure immediately before initiation of intervention/sham procedure as measured by plethysmography (standard inflatable blood pressure cuff). |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
vital signs - oxygen saturation in the blood during the intervention/sham procedure |
maximum change in blood oxygen saturation (measured as % saturation) during the intervention/sham period versus the baseline immediately before initiation of intervention/sham procedure as measured by pulse oximeter. |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
tolerability - vital signs - cardiac output |
maximum change in cardiac output during the intervention/sham period versus the baseline immediately before initiation of intervention/sham procedure as measured by NICaS bioimpedance device. |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|
Secondary |
vital signs - cardiac output during the intervention/sham procedure |
maximum change in cardiac output (liters/minute) during the intervention/sham period versus the baseline immediately before initiation of intervention/sham procedure as measured by NICaS bioimpedance device. |
at each intervention/sham procedure - these occur 3 days per week for 6 weeks at the beginning of the study |
|